Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problems
Degraded (1153); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 12/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Litigation record received.Litigation alleges elevated cobalt levels in the blood resulting to pain, scarring, disfigurement and loss of function.Doi: 2009; dor: (b)(6) 2016; unknown hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.Replaced surgical intervention with device revision or replacement.
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Event Description
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Medical records reported that the patient asr resurfacing was revised due to acetabulum fracture transverse posterior wall, developed collapse posterior wall with subluxation of femoral head into posterior wall hardware with grooving of the head and loss of articular cartilage.Asr resurfacing was revised with pinnacle construct on (b)(6) 2009 and pinnacle implants were revised on (b)(6) 2016 however, reason for revision were unknown.
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Event Description
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After a review of medical records patient was revised due to failed mom tha with metallosis and abductor necrosis, operative notes indicated elevated metal ions however laboratory results showed below normal level, mri shows consistent mom corrosion and pseudotumor formation.Upon entering the joint, the fluid was under tension and had evidence of metal debris.The taper and bearing surface of the femoral head had corrosion.There was evidence of corrosion at the taper of the liner acetabular component interface with pseudomembrane formation on the undersurface of liner.The femoral stem was in excessive anteversion minimizing combined version malpositioning.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Search Alerts/Recalls
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